pionERA Breast Cancer | Clinical Research Studies Listing

Enrolling By Invitation

18-100 years

Female

Phase 3

Brief description of study

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Detailed description of study

This study is Enrolling by Invitation only at Lancaster General Hospital - ABBCI.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: In clinic, in person
Age: Between 18 Years - 100 Years
Gender: Female

Inclusion Criteria:

Locally advanced or metastatic adenocarcinoma of the breast, not amendable to treatment with curative intent
Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or archived tumor sample)
Confirmed ESR1 mutation status (ESR1m vs. ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
Resistance to prior adjuvant endocrine therapy (ET). Prior use of neo/adjuvant CDK4/6i is allowed
No prior systemic anti-cancer therapy for advanced disease
Measurable disease as defined per RECIST v.1.1 or non-measurable bone-only disease
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
For pre/perimenopausal women and for men: treatment with LHRH agonist therapy (as per local guidelines) for the duration of study treatment is required

Exclusion Criteria:

Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
Active cardiac disease or history of cardiac dysfunction
Clinically significant history of liver disease

Updated on 01 Aug 2024. Study ID: CO44657 pionERA

If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For cancer trials contact EmergingMed: 1-855-216-0098 or PennCancerTrials@emergingmend.com